Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer

UNICANCER60 enrolled

Overview

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.

OBJECTIVES: Primary * Determine the efficacy of capecitabine and oxaliplatin as first-line treatment, as defined by stabilization or improvement by 1 point on Katz's Activities of Daily Living scale, in older patients with metastatic colorectal adenocarcinoma. Secondary * Determine the toxicity of this regimen in these patients. * Determine the percentage of patients who receive the first 3 courses of this regimen (at lower doses) and the percentage of patients who receive all 6 courses of this regimen (at both lower and higher doses). * Determine efficacy of this regimen, as defined by RECIST criteria, in these patients. * Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a multicenter, open-label, nonrandomized study. Patients receive oral capecitabine\* once daily on days 1-14 and oxaliplatin\* IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. NOTE: \*The doses of both capecitabine and oxaliplatin are increased in courses 4-6 in the absence of unacceptable toxicity PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

capecitabineDRUG

oxaliplatinDRUG

Eligibility

Sex: ALLMin age: 70 YearsMax age: 120 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of colorectal adenocarcinoma * Metastatic disease * Requires first-line therapy for metastatic disease PATIENT CHARACTERISTICS: Age * Over 70 Performance status * Katz's Activities of Daily Living scale \< 6 (≤ 6 for patients ≥ 80 years of age) Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * AST and ALT \< 2 times normal (5 times normal if due to hepatic metastases) * Bilirubin \< 2 times normal (5 times normal if due to hepatic metastases) Renal * Creatinine clearance \> 30 mL/min Other * No clinical neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 6 months since prior adjuvant chemotherapy * No prior chemotherapy for metastatic disease Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Locations (9)

Centre Regional Francois Baclesse

Caen, France

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, France

Hopital Europeen Georges Pompidou

Paris, France

Polyclinique Francheville

Périgueux, France

Outcomes

Primary Outcomes

Efficacy in terms of stabilization or improvement by 1 point on Katz's Activities of Daily Living scale

Secondary Outcomes

Toxicity

Percentage of patients who receive the first 3 treatment courses at a lower dose and the percentage of patients who receive all 6 treatment courses at both lower and higher doses

Efficacy as defined in RECIST criteria

Pharmacokinetics

Data from ClinicalTrials.gov

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